CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 11 enrolled
Drug / intervention
Coagulation Factor VIIa variantbiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03407651
NCT03407651Phase 2Completed
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Phase 2 Study to Evaluate the Pharmacokinetics, Efficacy and Safety of a Daily Subcutaneous Treatment Regimen With Marzeptacog Alfa (Activated) for Bleeding Prophylaxis in Adult Subjects With Hemophilia A and B Subjects With an Inhibitor

Catalyst Biosciences·interventional·Posted Jan 23, 2018·Updated Sep 23, 2021

In Brief

A Phase 2 clinical trial evaluating Coagulation Factor VIIa variant for Hemophilia A With Inhibitor and Hemophilia B With Inhibitor. Completed, enrolled 11 participants across 9 sites in 5 countries.

Detailed Summary

Phase 2, multi-center, open-label study designed to evaluate the PK, bioavailability, PD, efficacy and safety of a daily subcutaneous \[SC\] treatment regimen with MarzAA for bleeding prophylaxis in 12 adult subjects with hemophilia A or B with an inhibitor and history of frequent spontaneous bleeding episodes.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHemophilia A With Inhibitor, Hemophilia B With Inhibitor
CountriesArmenia, Georgia, Poland, Russia, South Africa
Collaborators--

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedJan 23, 2018
Enrollment StartDec 18, 2017
Primary CompletionMar 15, 2019
Study CompletionApr 13, 2019
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 8.4 years ago

Interventions

Coagulation Factor VIIa variantbiological

Single intravenous injection of MarzAA, followed by single subcutaneous injection of MarzAA, followed by daily subcutaneous injection of MarzAA for 50 days at final dose level required.